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OpenTrials
Completed

NCT Number: NCT03592043

A Pan-Canadian, Retrospective Evaluation of MitraClip Safety and Efficacy

The PREMISE Registry is a retrospective, observational study that will evaluate the efficacy and safety of the MitraClip in real-world Canadian practice. It will include all patients who have undergone MitraClip implantation in Canada to date.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

About this study

In addition to evaluating efficacy and safety, PREMISE will include a description of patient demographics, etiology of mitral regurgitation, co-morbidities, medication use and functional class. It will also compare re-hospitalization for heart failure 12 months prior and 12 months after the procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has undergone percutaneous mitral valve repair with MitraClip Clip Delivery System in Canada

Exclusion criteria

  • none

Treatment and study plan

mitraclip

Device

Transcatheter Mitral Valve Repair with MitraClip

Other names: MitraClip Clip Delivery System

Primary outcomes

  1. Mitral Regurgitation (MR) severity

    Time frame: 12 months

Secondary outcomes

  1. Hospitalization for Heart Failure

    Time frame: 12 months

  2. All-cause mortality

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

A Retrospective Multicenter Canadian Registry of Patients With Mitral Regurgitation Undergoing Percutaneous Mitral Valve Repair With MitraClip

Acronym: PREMISE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2018
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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